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isosorbide dinitrate and hydralazine hydrochloride

NDC 72319-012 · i3 Pharmaceuticals, LLC

Generic nameisosorbide dinitrate and hydralazine hydrochloride
Dosage formTABLET, FILM COATED
RouteORAL
Active ingredient(s)ISOSORBIDE DINITRATE, HYDRALAZINE HYDROCHLORIDE
Strength37.5; 20 mg/1; mg/1
Pharmacologic classArteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC], Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
Marketing categoryANDA

Packages

72319-012-03 — 90 TABLET, FILM COATED in 1 BOTTLE (72319-012-03)

72319-012-18 — 180 TABLET, FILM COATED in 1 BOTTLE (72319-012-18)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

71872-7339 — HYDRALAZINE HYDROCHLORIDE, 72162-1521 — Hydralazine Hydrochloride, 72162-1535 — Hydralazine Hydrochloride, 72162-1536 — Hydralazine Hydrochloride, 72162-1537 — Hydralazine Hydrochloride, 72162-1538 — Hydralazine Hydrochloride, 72162-2343 — hydralazine hydrochloride and isosorbide dinitrate, 72241-004 — hydralazine hydrochloride, 72241-005 — hydralazine hydrochloride, 72241-006 — hydralazine hydrochloride, 72572-265 — Hydralazine Hydrochloride, 72888-081 — isosorbide dinitrate, 72888-082 — isosorbide dinitrate, 72888-083 — isosorbide dinitrate, 72888-084 — isosorbide dinitrate, 72888-085 — isosorbide dinitrate, 73141-012 — isosorbide dinitrate and hydralazine hydrochloride, 75834-126 — HYDRALAZINE HYDROCHLORIDE, 75834-127 — HYDRALAZINE HYDROCHLORIDE, 75834-128 — HYDRALAZINE HYDROCHLORIDE, +194 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q3 (July 2026 release). All data sources · How to read the labels